January 10, 2017

White House Takes Final Steps to Revamp “The Common Rule” Medical Research Rule

From: BNA

By Jeannie Baumann

The final revisions to human research regulations arrived at the OMB, an indication that the first-ever overhaul of the so-called Common Rule will likely be released before President Barack Obama leaves office Jan. 20.


No Guarantees

The OMB Office of Information and Regulatory Affairs has up to 90 days to review the final rule, so there is no guarantee a new Common Rule will move forward by Jan. 20. The OIRA/OMB review is the last required step before final rules can be published in the Federal Register, Gary Chadwick, a senior consultant with HRP Consulting Group, told Bloomberg BNA. Chadwick previously served as the associate director for human subject protections for both the OHRP and the FDA.

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